Manager, Quality Systems

Please note that this position can be based in San Diego CA OR San Francisco CA OR Princeton NJ. Acadias hybrid model requires this role to work in our office three days per week on average.

Position Summary:

This role supports the administration oversight and continuous improvement of the electronic Quality Management System (eQMS) including Deviation CAPA and Change Management processes. The position ensures quality records are compliant complete and closed within established timelines while maintaining alignment with regulatory and business addition to process support this role provides QMS system administration testing reporting and end-user guidance to ensure the quality system operates effectively and supports inspection readiness.

Primary Responsibilities:

Provides support for the implementation and maintenance of the quality systems program.

Assists with the oversight of the Corrective and Preventive Action (CAPA) process to ensure CAPAs and associated records are reviewed and completed in a timely and compliant manner.

Assists with the oversight of the Change Management program to ensure continuous compliance of the Quality System. Assist with ensuring timely completion/closure of change management records.

Assists with the oversight of the Deviation process to ensure deviations and associated records are reviewed and completed in a timely and compliant manner.

Provides support and training to end users for processing Deviation investigations CAPAs and Change Management.

Management of electronic Quality Management System (QMS) (e.g. Veeva Vault QMS) including troubleshooting issues through testing in Veeva Sandbox review and execution of PQ scripts within Veeva Test environment.

Ensures quality systems procedures systems and processes are effective and meet regulatory requirements and business needs.

Provides support for Quality System metrics including review and identifying/addressing support for internal audit and regulatory inspections of quality management systems.

Provides QMS Business Administrator support to end users (e.g. reassigning tasks updating picklists or objects creating reports and dashboards.)

Other duties as assigned.

Education/Experience/Skills:

Bachelors degree in Life Sciences or an equivalent combination of relevant education and applicable job experience may be considered. A minimum of 3 years Quality Systems experience.

Requirements:

Proficiency in Microsoft Excel Word and Outlook.

Critical thinking skills in analyzing and exercising judgement on complex issues guided by a thorough understanding of quality philosophy.

Strong focus on flexibility ability to multi-task attention to detail excellent organizational skills good follow-up and judgment and ability to prioritize.

Skilled at effectively communicating department or area issues and results within and across functional areas.

Able to gain cooperation of others.

Required Experience:

Manager